Implementation of Machine Learning and Hemodynamic Profiles Based Clinical Decision Support Systems for Personalized Guideline Accordant Antihypertensive Regimens in Primary Care: a Pragmatic Cluster Randomized Controlled Trial

This trial is a prospective, multicenter, single-blind, three-arm parallel-group, cluster randomized controlled trial assessing the effectiveness and safety of two types of CDSS in primary care settings in China. Primary care sites are randomized to one of the intervention arms or the control arm (1:1:1 ratio) using computer-generated random numbers stratified by region and administrative categories of the primary healthcare institutions (including community health centers, community health stations, and township health centers). A total of 51 primary care sites are randomized to three groups, with 17 sites assigned to group A (use a CDSS based on clinical guidelines and machine learning), 17 sites to group B (use a CDSS based on guidelines, hemodynamic parameters and ML), and the remaining 17 sites to the control group.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Combination product: Group A (clinical guideline+machine learning); Combination product: Group B (clinical guideline+impedance cardiograph+machine learning); Other: Group C (usual care)

• Study Type: Interventional
• Enrollment (Estimated): 2160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaofang Yan; Phone Number: 0086 10 60686871; Email: yanxiaofang@fuwai.com
• Study Contact Backup: Name: Xin Zheng; Phone Number: 0086 10 60866719; Email: zhengxin@fuwai.com

Study Locations

• China
  • Shenzhen
    • Shenzhen, Shenzhen, China
      • Recruiting
      • Fuwai Shenzhen Hospital, Chinese Academy of Medical Sciences
      • Contact: Xiaofang Yan; Phone Number: 0086 1358186128; Email: yanxiaofang@fuwai.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 35 ≤ Age < 80 years.
2. Regularly attend the clinic for hypertension treatment during the study period, without plans of traveling during the study period.
3. Diagnosed with hypertension, with SBP ≥140mmHg at screening.
4. Currently taking 0 or 2 classes of antihypertensive medications (A/C/D), with or without concurrent use of class B.
5. Willing to participate in the trial and capable of providing written informed consent.

Exclusion Criteria:

1. Physician-diagnosed or suspected secondary hypertension (e.g., hypertension caused by renal disease, renal artery stenosis, aortic stenosis, primary aldosteronism, pheochromocytoma/paraganglioma, Cushing's syndrome, thyroid dysfunction, intracranial disease, drug-induced, or rare monogenic genetic disease).
2. SBP ≥180mmHg and/or DBP ≥110mmHg at the screening visit.
3. Suspected or diagnosed white coat hypertension.
4. History of coronary heart disease.
5. History of heart failure.
6. Intolerance to 2 or more classes of A, C,D antihypertensive medications.
7. Currently taking antihypertensive medications other than class A,B,C and D.
8. Diagnosed chronic kidney disease, estimating Glomerular Filtration Rate (eGFR)< 60 ml/min·1.73m2, or receiving dialysis.
9. Serious medical conditions (e.g., malignant cancer and hepatic dysfunction)
10. Currently in an acute episode of disease (e.g, new-onset cardiovascular and cerebrovascular disease occurred within 3 months).
11. Cognitive or communicative disorders.
12. Currently pregnant or breastfeeding or planning a pregnant or breastfeeding during the study.
13. Reluctant to take antihypertensive medications or have poor compliance with previous treatment.
14. Participating in other clinical trials.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (CG+ML)	Combination product: Group A (clinical guideline+machine learning); Group A (CG+ML): A Clinical Decision Support System (CDSS) with the algorithm that incorporates clinical guideline (CG) and machine learning (ML) approach.
Experimental: Group B (CG+ICG+ML)	Combination product: Group B (clinical guideline+impedance cardiograph+machine learning); Group B (CG+ICG+ML): A Clinical Decision Support System (CDSS) with the algorithm that incorporates clinical guideline (CG), hemodynamic parameters measured by impedance cardiograph (ICG), and machine learning (ML) approach.
Other: Group C (UC)	Other: Group C (usual care); Control group, the physicians manage the hypertensive patients according to their knowledge and experiences.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hierarchical composite outcome	The primary outcome of the trial is a hierarchical composite outcome, evaluated using the Win-ratio method in the following order: Office blood pressure control rate (<130/80 mmHg) at 3 months after randomization.; The duration from baseline to the first occurrence of controlled blood pressure achievement (<130/80 mmHg) within 3 months after randomization.; The composite index of the number and dosage of antihypertensive drugs among participants achieved controlled blood pressure at 3 months after randomization.	Baseline; 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Separate evaluation of each component of the three-tier hierarchical composite primary outcome at 3 months		Baseline; 3 months
Changes in office systolic and diastolic blood pressure from baseline to 1 month and 3 months		Baseline; 1 month; 3 months
Average 24-hour ambulatory systolic and diastolic blood pressure, along with blood pressure control rate at 3 months		3 months
Changes in hemodynamic parameters measured by ICG from baseline to 3 months	Including dynamic parameters (heart rate and cardiac index), resistance parameters (arterial stiffness index and systemic vascular resistance index), and volume parameters (thoracic blood volume saturation)	Baseline; 3 months
Differences in the three-tier hierarchical composite primary outcomes and each component of the three-tier hierarchical composite primary outcome among intervention groups at 3 months		Baseline; 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety outcome	Safety outcomes include serious adverse events, non-serious adverse events, such as symptomatic hypotension or SBP <90 mmHg, injury falls, syncope, and bradycardia (heart rate <50 beats/minute) during study periods.	Baseline; 3 months

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Xin Zheng, Fuwai Hospital, China Academy of Medical Sciences, National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2025
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: February 6, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): February 14, 2025

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Hypertension; cluster randomized controlled trial; CDSS
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: NCRCSZ-2023-014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No